Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more— 510(k) K223376
Substantially EquivalentCardinal Health200, LLC
FDA 510(k) clearance K223376 for Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) +2 more, Substantially Equivalent on 2023-06-21. Applicant: Cardinal Health200, LLC. Device class: 2.
Clearance details
- Device name as filed
- Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)
- Applicant
- Cardinal Health200, LLC
- Product code
- Code MEG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5860
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Waukegan, IL, US
Recent devices under product code MEG
view allMore clearances from Cardinal Health200, LLC
view all- K241780 — Cardinal Health Nitrile Exam Gloves
- K230838 — Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets
- K230028 — Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
- K201592 — Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove
- K211390 — Nitrile Blue Powder-free Examination Glove
Adverse events under product code MEG
product code MEG- Malfunction
- 1,373
- Other
- 1
- Total
- 1,374
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.